About HOOKIPA:

HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies that mobilize and amplify targeted T cells to address unmet needs in cancer or to fight infectious diseases.

HOOKIPA is leveraging its proprietary, versatile platform to engineer a broad pipeline of differentiated arenaviral therapeutics. These novel immunotherapies induce robust antigen-specific killer T cells to a broad range of self and non-self antigens, including viral antigens, tumor-associated antigens and neoantigens. HOOKIPA’s platform technology uses replicating viral vectors based on the target cancer, with the potential to induce killer T cell response levels previously not achieved by other immunotherapy approaches.

HOOKIPA’s pipeline includes wholly-owned investigational arenaviral immunotherapeutics targeting HPV16+ cancers, prostate cancer, KRAS-mutated cancers (including colorectal, pancreatic and lung), and other undisclosed projects. In addition, the company aims to develop functional cures of HBV and HIV in collaboration with Gilead

Position Summary:

We are looking for an experienced Clinical Drug Supply Manager (m/f), who plans and executes on an optimal clinical trial supply strategy for Hookipa´s clinical trials, ensuring effective risk management and supply continuity to patients in the trials. 

The position requires excellent communication skills and best-in-class teamwork with internal and external partners.

Main Responsibilities:

• Be key account manager for CMOs for labeling and packaging activities of final drug product, transfer to and storage at drug depot, as well as for distribution logistics from drug depot to clinical sites. Acts as the primary liaison between the CMO and Contract Research Organization (CRO), who is supporting the clinical site management.
   
• Works on drug demand forecasting and planning of clinical trial supply.
• Planning, monitoring and control of investigational medicinal product (IMP) relevant activities related to labeling and re-labeling, packaging, storage and distribution logistics of clinical trial material.
• Develop a labeling strategy that meets respective regulatory and study specific requirements. Lead the development and approval of label text and label proofs including country-specific translations, as needed.
• Set up distribution strategies to ensure that all relevant parameters are considered for trial supply; defining Interactive Response Technology (IRT) set-up from a drug supply perspective (e.g., initial or re-supply quantities); align with internal and external stakeholders on any quality/QP, project, study, expiry, customs, import/export, brokerage, or country specific requirements to enable smooth execution of clinical trial supply throughout the study.
• Review clinical trial protocol/protocol amendments and other related documents (e.g., Pharmacy manuals).
• Provide input to develop efficient packaging design, clinical trial supply design and patient visit schedule.
• Contribute to the budgeting and forecasting for clinical studies, offer creative solutions/proposals to optimize the clinical supply chain.
   
• Monitor ongoing clinical study activity level to ensure sufficient (re-) supply. Manage inventory targets and safety stock levels. Manage any potential supply related risks on an operational level and communicate/escalate any potential risk if supply forecast is at risk.
• Ownership of all clinical drug supply related activities from the receipt at the initial depot through destruction. This includes depot-to-depot shipments and depot-to-site shipments. Any transfer should be proactively managed, and any issue e.g., temperature deviations should be owned and resolved promptly in alignment with Quality Management.
• Review and provide input and approval for set up of user requirement specifications for the IRT system. Interact with the IRT vendor and provide feedback of the clinical trial design to ensure optimal functionality and use of the IRT.
• Support preparation of clinical study manuals/documents including the pharmacy manual, eTMF updates, regulatory filings and QP declarations.
• Actively participates in internal project team meetings to work with cross functional teams including Clinical Operations, Quality Management, Regulatory Affairs, and CMC to provide feedback and input from a clinical supply chain perspective.
• Actively participates and represents clinical drug supply function in meetings with CROs, as needed.
   

Qualifications:

• 3+ years' experience in clinical trial drug supply management at bio/pharmaceutical industry.
• Bachelor’s Degree in Life Sciences, Business, Engineering, Supply Chain Management or related field. MSc/MBA is desirable.
• Very good command of English (B2 level or higher).
• Excellent communication and inter-personal skills.
• Hands-on, solution-oriented personality.
• Strong quantitative and analytical skills with excellent attention to detail.
• General knowledge of current GMP/GCP/GDP regulations.
• Experience in clinical packaging and labelling, drug depot warehousing & IMP transportation/distribution.
• General knowledge of Interactive Response Technology (IRT) system.
• Proficiency with Excel modeling or other planning systems.
• Experience with drafting a pharmacy manual for IMP logistics, preparation, and administration.
• Experience with IMPs that are biologics and given as IV formulation is a plus.
• Experience in working in a highly matrix organized environment with demonstrated leadership skills.
• Collaborative team player with strong interpersonal skills and ability to drive team actions and results.
• Experience in CMC fields is a plus.
   

What we offer:

• Strong team with dedicated and passionate researchers
• State of the art infrastructure
• Excellent working atmosphere
• Opportunities for personal development
• Employee benefits such as health screening, public transportation card, Sodexo pass
• Working in a multinational and multicultural environment
   

We are required by Austrian law to post a minimum salary. The minimum monthly gross salary for this position is EUR 4.394, - based on fulltime (14 monthly salaries per annum/ 40 hours per week); depending on experience and qualification the salary can be negotiated. In addition, we offer a performance-related bonus payment and participation in our stock option compensation program.

Starting date: as soon as possible

Contact:

If you (m/f/d) are interested in this challenging position, please send us your CV including a cover letter (summarizing your qualification and experiences) as well as your credentials.

For more information on HOOKIPA please visit www.hookipapharma.com